Lebrikizumab provides stable skin response with no or minimal fluctuations for up to 2 years in patients with atopic dermatitis

Background Lebrikizumab, a novel monoclonal antibody targeting interleukin-13, demonstrated durable and deep response on skin and itch in patients treated for 104 weeks in recent phase 3 trials (ADvocate1, NCT04146363; ADvocate2, NCT04178967; ADjoin, NCT04392154). Objective This analysis assessed stability of response through 2 years of continuous lebrikizumab treatment in Week 16 responders from ADvocate1 and ADvocate2 who continued the same treatment (lebrikizumab every 4 weeks [Q4W], N=99; lebrikizumab every 2 weeks [Q2W], N=82) in long-term extension study ADjoin. Methods Week 16 response was defined as Investigator’s Global Assessment 0/1 with ≥2-point improvement from baseline or a ≥75% reduction in Eczema Area and Severity Index (EASI-75) without rescue medication. Stability was measured for EASI-75, EASI-90, and Pruritus Numeric Rating Scale (NRS) ≥3-point and ≥4-point improvement from baseline among Week 16 responders who had achieved the specified endpoint at Week 16. Stability was defined as maintenance of response for ≥80% of attended study visits from Weeks 16 through 104 (ADjoin Week 52). Observed data were analyzed regardless of rescue medication or discontinuation from treatment. Results With 104 weeks of continuous lebrikizumab treatment, 96.0% and 81.0% of Week 16 responders receiving lebrikizumab Q4W (91.5% and 79.2% for Q2W) showed stable EASI-75 and EASI-90 responses, respectively. Similarly, 93.8% and 87.9% of responders receiving lebrikizumab Q4W (88.7% and 87.2% for Q2W) showed stable responses for Pruritus NRS ≥3-point and ≥4-point improvement, respectively. Conclusions A majority of lebrikizumab Week 16 responders maintained stable efficacy in measures of skin and itch during 2 years of treatment.